Developing an ART Adherence Intervention in South Central China

在中国中南部开展 ART 依从干预措施

• 批准号: 7756339
• 负责人: Ann Bartley Williams
• 金额: $ 28.02万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-06 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7756339
• 关键词: Adherence; Antiretroviral resistance; Centers for Disease Control and Prevention (U.S.); China; Chinese People; Clinical Trials; Communities; Development; Disease; Effectiveness; Future; HIV; Incidence; Intervention; Knowledge; Mutation; Patients; Pilot Projects; Prevalence; Provider; Province; Randomized; Randomized Clinical Trials; Resistance; Resources; Social Environment; Staging; Technology; Testing; Time; Treatment Protocols; United States; Work; antiretroviral therapy; clinical care; clinically significant; design; improved; programs; response; scale up; therapy adherence

Description (provided by the applicant): This is a developmental project to design and test the feasibility and preliminary efficacy of a culturally appropriate intervention for supporting antiretroviral therapy (ART) adherence in South Central China, in a resource-constrained setting where the national CDC is presently scaling up ART-treatment. We will adapt a theoretically driven ART adherence intervention, which demonstrated efficacy in a randomized clinical trial conducted in the United States, to the Chinese cultural and social context. The adaptation will be informed by the results of our preliminary quantitative and qualitative work in this region of China and will be validated by patient, provider, and community review groups. We will conduct a randomized, controlled pilot study of the feasibility and acceptability of the intervention among 90 patients beginning ART through the China national ART program in Hunan Province and establish a preliminary effect size in anticipation of a full-scale clinical trial. We will also use Ultra Deep Sequencing technology to describe baseline prevalence and incidence of genotypic ART resistance and explore the relationship between adherence and ART resistance. Knowledge acquired from this study will contribute to successful treatment of HIV disease through increased understanding of factors associated with ART adherence and interventions to support or improve adherence and through increased understanding of the clinical significance of genotypic mutations, including low abundance species, and the value of genotypic testing as part of clinical care. These benefits will accrue to patients in both the developed and developing world. The opportunity to acquire this knowledge is unique and time-limited, because China is in the early stages of an ambitious and well-organized ART roll out.

描述（由申请人提供）：这是一个开发项目，用于设计和测试在中国中南部的抗逆转录病毒疗法（ART）遵守抗逆转录病毒疗法（ART）的可行性和初步疗效，在资源受限的环境中，国家CDC目前正在扩大艺术范围。我们将适应理论上驱动的艺术依从性干预措施，该干预措施在美国进行的随机临床试验中证明了功效，以适应中国的文化和社会环境。我们的初步定量和定性工作的结果将为适应，并将得到患者，提供者和社区审查小组的验证。我们将对90名患者的干预措施的可行性和可接受性进行随机，受控的试点研究，这是通过匈牙省的中国国家艺术计划开始艺术的，并在预期进行全尺度临床试验的情况下建立了初步效果大小。我们还将使用超深的测序技术来描述基线的流行率和基因型ART耐药性的发生率，并探索依从性与抗Art抗性之间的关系。从这项研究中获得的知识将通过对与艺术依从性和干预措施相关的因素的了解，以支持或提高依从性以及对基因型突变的临床意义（包括低丰度物种）的临床意义以及作为临床护理的一部分的基因型测试的价值增加，从而有助于成功治疗HIV疾病。这些好处将给发达国家和发展中国家的患者带来。获取这一知识的机会是独特且限时的，因为中国处于雄心勃勃且组织良好的艺术作品的早期阶段。